The results showed improvement in the primary end point, which was defined as a reduction in facial erythema, over an eight hour period in patients with erythematotelangiectatic rosacea (ETR), compared to placebo
In addition, V-101 demonstrated a safety profile similar to placebo cream, without any evidence of ‘rebound’ or tachyphylaxis.
Vicept said the prospectively randomised, multi-centred, double-blinded, placebo-controlled, Phase II clinical trial was designed to assess the dose-response relationship of four concentrations of V-101 cream versus placebo for the treatment of the erythema associated with rosacea.
The study enrolled a total of 183 patients with moderate to severe erythema at seven investigational centers across the US.
Patients were divided among five groups and self-administered one of four concentrations of V-101 cream or placebo cream, once daily for 28 days.